Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740132545
• Version / Model: 09P8301
• Catalog Number: 09P8301
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-16
• Public Version: 1
• Public Version Date: 2023-11-24
• Public Version Status: New
• Public Device Record Key: 8c03bf5b-6763-4bdd-9c15-73766f522618

Device Description

Alinity h-series Smear Tape Cartridge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPA	Slide stainer, automated	Pathology	864.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62927	Blood smearing cassette IVD	A device designed to be inserted into an automated microscope slide processing instrument (e.g., microscope slide maker) to create a blood smear on a microscope examination slide for subsequent staining and/or microscopic analysis. It is in the form of a cassette tape with a roll of spaced blades which individually make contact with a single blood drop to produce a smear. This is a reusable device intended to be discarded after all blades have been used once.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740132545	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius